Many vascular procedures are performed using minimally invasive techniques, often by accessing the femoral artery or another major blood vessel through a puncture opening made in the blood vessel, and accessing a surgical site via the blood vessel. Upon completion of the procedure, the puncture opening must be closed. The goal of repair of the puncture opening is to create hemostasis in tissue of the tissue tract leading to the blood vessel wall, and to allow the puncture opening to seal. Sealing the puncture opening allows blood to eventually flow again through the blood vessel without thrombosis or embolism, and allows the tissue in the tissue tract leading to the vessel to heal.
The earliest technique for closing a puncture opening was the simple application of direct physical pressure, either by a medical professional, and/or by a simple clamp. A drawback of direct pressure is that is it often painful for the patient, and requires extended immobilization of the patient and attention of the medical professional.
As an alternative to direct pressure, various devices for wound closure at a vascular puncture site have been developed, including biodegradable plugs, sutures, staples, ultrasound, collagen, collagen with thrombin, collagen with an anchor, and hemostatic patches and pads. Typically, these devices and technique are generally effective for closing punctures having that are suitable for delivery of up to 16 French endovascular systems.
Commercial alternatives to direct pressure include:                Angio-Seal™ Vascular Closure Device (St. Jude Medical, Inc., St. Paul, Minn.)        Perclose™ (Abbott Laboratories, Abbott Park, Ill.)        VasoSeal™ (Datascope, Montvale, N.J.)        Duett™ (Vascular Solutions, Minneapolis, Minn.)        HeartStitch® (Sutura, Fountain Valley, Calif.)        Syvek® hemostasis products (Marine Polymer Technologies, Inc., Danvers, Mass.)        
U.S. Pat. No. 6,743,195 to Zucker describes apparatus for hemostasis of an artery having a puncture after arterial catheterization. The apparatus includes a catheter introducer having a forward end, and a hemostasis device including an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof, and an inflatable peripheral balloon adjacent the forward end of the flexible hollow shaft. The hemostasis device is arranged to be insertable into an artery via the catheter introducer.
U.S. Pat. No. 7,731,732 to Ken describes a closure device for closing a puncture wound having a distal section that can be placed against the interior wall of a vessel, and a proximal section that bunches in the tissue tract to close the wound. One variation of the device provides for removing the distal section from the vessel so that it resides also in the tissue tract after the proximal section has been securely bunched and lodged within the tissue tract in order to provide unobstructed fluid flow in the vessel.
The following patents may be of interest:
U.S. Pat. No. 5,527,322 to Klein et al.
U.S. Pat. No. 5,613,974 to Andreas et al.
U.S. Pat. No. 5,728,134 to Barak
U.S. Pat. No. 5,860,991 to Klein et al.
U.S. Pat. No. 5,921,994 to Andreas et al.
U.S. Pat. No. 6,117,145 to Wood et al.
U.S. Pat. No. 6,206,893 to Klein et al.
U.S. Pat. No. 6,846,321 to Zucker
U.S. Pat. No. 7,008,441 to Zucker
U.S. Pat. No. 7,115,127 to Lindenbaum et al.
U.S. Pat. No. 7,223,266 to Lindenbaum et al.
U.S. Pat. No. 7,662,168 to McGuckin, Jr. et al.
U.S. Pat. No. 7,662,161 to Briganti et al.
US Patent Application Publication 2006/0167476 to Burdulis, Jr. et al.